NCT07355621

UP-818-CC Injection in Healthy Chinese Subjects

A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of UP-818-CC Injection in Healthy Chinese Subjects After Single-dose and Multiple-dose Intravenous Infusion

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: EnliTISA (Shanghai) Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study are to evaluate the safety, tolerability and pharmacokinetic characteristics in healthy Chinese volunteers after single and multiple dose of intravenous infusion of UP-818-CC. This study is divided into two parts, single ascending dose part (SAD) and multiple ascending dose part (MAD), both conducted in healthy subjects, using a randomized, double-blind, placebo-controlled, dose-escalating design. The SAD part is planned to be carried out in 6 dose groups. A total of about 43 healthy adult subjects are planned to be included. All subjects will receive a single dose on the first day (D1). According to the obtained PK and safety information of the SAD, three appropriate dose groups are selected in MAD. A total of about 30 healthy adult subjects, both male and female, will be included. All subjects will receive multiple doses from D1 to D7, once daily.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	UP-818-CC injection	UP-818-CC injection
OTHER	Placebo	placebo

Timeline

• Start date: 2022-02-14
• Primary completion: 2023-01-12
• Completion: 2023-02-20
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: China